The regulatory environment for pharmaceutical advertising in the United States is shifting quickly. In the wake of the Trump Administration’s recent presidential memorandum and the FDA’s latest enforcement actions, pharmaceutical marketers, regulatory affairs professionals and agencies are facing new compliance challenges.

Recently we sat down with experts Tish Pahl (OFW Law) and Jim Potter (Coalition for Healthcare Communications) to outline what these developments mean in practice — and how brands should respond. 

This post highlights five essential takeaways from Tish and Jim’s expert perspectives, covering the Administration’s three-pronged initiative, including policy shifts, enforcement trends and practical strategies that pharma marketers need to know now.

1. The Presidential Memorandum Set the Tone — Without Creating New Law

On September 9, 2025, the White House issued a memorandum directing HHS and FDA to increase oversight of direct-to-consumer (DTC) advertising. The memo criticized DTC ads for misleading patients about risks and benefits, promoting medication over lifestyle changes, undermining physician-patient relationships and favoring costly therapies over generics.  

“This was not an executive order… it was a memorandum,” says Jim Potter, Executive Director, Coalition for Healthcare Communication of the recently released materials from the White House.¹ “Think of it more like a public email to the HHS Secretary.”

But while the communications do not carry the weight of an executive order, the memo did send a strong political message: DTC advertising is under the microscope. The language signaled urgency and gave FDA and HHS a green light to step up enforcement using existing statutory authority.

The Takeaway for Brands & Pharma Marketers: Marketers should treat the memo as a sign to stay vigilant on ad compliance. Even without new law, FDA can increase enforcement under current requirements, or may reinterpret existing advertising standards to hold ads accountable under broader standards of truthfulness and balance.

2. FDA Enforcement Is Escalating — Untitled and Warning Letters Provide Clear Lessons

Following the memorandum, FDA initiated a sweeping enforcement campaign:

• Thousands of drug application holders received a form letter reminding them of promotional obligations.
• Issuance of over 50 Untitled Letters, with the majority flagging broadcast ads that used distracting visuals during the major statement of risk disclosures or presented overly positive, “happy patient” imagery.
• Untitled Letters also targeted HCP advertising, including webpages, sales aids and booth panels. These ads were cited for claims that weren’t supported by clinical data and omitted risk information
• Issuance of over 60 Warning Letters, including more than 50 to GLP-1 compounders; other warning letters cited companies for failure to include risk information and inadequate risk disclosures in Google sponsored links.¹²

Untitled letters often targeted commercials that failed the “clear, conspicuous, and neutral” (CCN) standard — for example, upbeat imagery paired with side-effect narration that FDA argued misled viewers, and visuals and quick cuts that distracted viewers from the important major statement of risks. 

“Untitled letters are typically issued for what are referred to as lesser offenses. It’s less serious than a Warning letter,” says OFW Law’s Tish Pahl.¹ 

In contrast to an Untitled Letter, a Warning letter is a formal FDA notice for significant Federal Food, Drug, and Cosmetic Act (FD&C Act) violations, demanding corrective action and threatening potential enforcement like fines or seizures.

One case involved YouTube ads featuring a celebrity endorser that omitted all risk information. Other warning letters cited physician consultants interviewed on television programs, including a “Primetime Oprah Special,” who failed to direct viewers to adequate provision resources.¹²

The details underscore the heightened scrutiny on pharma companies from the FDA.

The Takeaway for Brands & Pharma Marketers: FDA’s enforcement actions show that both form and substance matter in pharma advertising.  Marketers must review pacing, imagery, testimonials and even third-party media appearances to ensure risk disclosures remain prominent and accurate. Also, FDA is not solely focused on DTC advertising but also on HCP advertising. 

To learn more about how you can ensure your messaging is compliant across both patient-facing and provider-facing channels, see POCMA’s post on aligning DTC and HCP communications.

3. Digital “Loopholes” May Be Targeted— Social and Emerging Media Are Under Scrutiny

As part of its enforcement announcement, the FDA emphasized its intent to expand oversight beyond traditional broadcast media and “close digital loopholes.” Specifically, the Agency intends to target: 

• Social media and influencer marketing.
• Algorithm-driven advertising, dark ads and AI-generated content.
• Platform-specific promotional strategies designed to evade detection.
• Emerging digital technologies and promotional methods.

Pahl and Potter both cautioned that, while the CCN rule technically is limited to broadcast and radio, they expect FDA to extend its principles to digital platforms, streaming, YouTube and even point of care screens.¹²  They believe it is prudent to assure that all video content, regardless of platform, include a major statement that aligns with the CCN rule.  

This shift reflects the reality that patients increasingly consume health information on digital and social channels. FDA is signaling that risk and benefit standards should travel with the message, regardless of the medium.

The Takeaway for Brands & Pharma Marketers: Marketers should apply CCN principles universally, across platforms and mediums, including assuring that any video presentation aligns with the CCN rule and that adequate provision is made.  Brands and marketers should also expect FDA scrutiny of influencer relationships.  All messages should disclose risks.  

4. The Adequate Provision Rule May Be Eliminated

The issuance of a guidance in 1999 helped FDA clarify its “Adequate Provision” requirements from the original 1960’s rulemaking which allows broadcast ads to direct consumers to alternative sources to obtain more information about the advertised drug.  Under this guidance, and the rule it interprets, broadcast ads can provide phone numbers, websites and refer consumers to print ads and doctors rather than repeat the detailed “brief summary” that includes all of a drug’s warnings, precautions, contraindications and effectiveness. FDA and HHS now propose eliminating this adequate provision option, arguing that it enables advertisers to “hide” safety information outside the ad itself. ¹²

If rescinded, ads may need to display full risk summaries on-screen — a fundamental shift in compliance requirements. The elimination of adequate provision could mandate inclusion of larger amounts of prescribing information directly in ads, which would likely be impossible in a typical broadcast or any other video presentation. However, such a change would likely bring litigation on potential conflicts with the Food, Drug & Cosmetic Act and Food and Drug Administration Amendments Act of 2007, as well as challenges involving the Administrative Procedures Act and First Amendment.

The Takeaway for Brands & Pharma Marketers: Marketers should begin scenario planning for ads that contain more information up front. Consider testing creative formats that can accommodate more safety language, stay mindful of how pacing and design would adjust campaigns and work with your legal teams to prepare for litigation that may follow FDA’s rulemaking process.

5. Point of Care Marketing Has Unique Advantages — But It’s Not Immune to This Changing Enforcement Landscape 

To date, no FDA Warning or Untitled letters have cited Point of Care (POC) communications directly. However, Pahl and Potter cautioned this could change, especially since many POC campaigns reuse broadcast creative and thereby inherit similar risks.¹²

Yet POC media also offers unique strengths:

• It provides trusted education, adherence and disease management support.
• It aligns with healthcare practitioners instead of bypassing them.¹

The Takeaway for Brands & Pharma Marketers: Marketers should continue to differentiate POC media by emphasizing its educational and provider-endorsed role, and ensuring all messaging at the POC meets these best practices. Developing POC content specifically tailored for the clinical setting — rather than repurposed from broadcast — can both reduce risk and elevate impact.

“This is an opportunity to leverage the relationship that point of care has with their physician providers to be sure that these are messages that the physician supports and wants their patients to be receiving,” says Pahl.¹

Remember That the Most Effective Ads Are Those That Educate & Guide

Educational messaging empowers HCPs, supports more informed patient conversations, and elevates the brand as a trusted, resource-first partner. Ensuring your messaging keeps education at its heart is a good place to start.

“The better that we as an industry can help educate, patients, consumers, caregivers — so when they come in, they have more effective conversations with their providers — that’s really got to be the goal,” says Potter.¹

Keep Calm & Carry On: Next Steps for Marketers

The DTC advertising landscape is changing fast. From new Untitled letters and Warning letters being issued by FDA to the proposed elimination of the Adequate Provision guidance, the regulatory climate is becoming more demanding.

Marketers must anticipate heightened scrutiny and adapt proactively by:

• Staying calm in the face of policy headlines and reacting to law, not speculation.
• Auditing campaigns across broadcast, digital, social and point of care media to ensure they follow all applicable rules and guidance and are aligned with recent enforcement actions. 
• Extending CCN principles universally to protect campaigns on emerging platforms.
• Positioning point of care content as educational and provider-endorsed.

Partner with POCMA member organizations to stay ahead of enforcement trends, learn best practices and ensure that your pharmaceutical marketing continues to support the vital physician-patient relationship.

1 POCMA Webinar Transcript, The New DTC Landscape: Breaking Down Policy Implications (September 2025)

2 Breaking Down Policy Implications Webinar Presentation (September 2025)